MINT-SIMVASTATIN TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

SIMVASTATIN

Disponível em:

MINT PHARMACEUTICALS INC

Código ATC:

C10AA01

DCI (Denominação Comum Internacional):

SIMVASTATIN

Dosagem:

20MG

Forma farmacêutica:

TABLET

Composição:

SIMVASTATIN 20MG

Via de administração:

ORAL

Unidades em pacote:

30/100/1000

Tipo de prescrição:

Prescription

Área terapêutica:

HMG-COA REDUCTASE INHIBITORS

Resumo do produto:

Active ingredient group (AIG) number: 0122415003; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2011-08-29

Características técnicas

_MINT-SIMVASTATIN_
_ _
_(simvastatin) _
Page 1 of 60
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-SIMVASTATIN
Simvastatin Tablets
Tablets, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg, Oral
USP
Lipid Metabolism Regulator
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario L5T 2M3
Date of Initial Authorization:
AUG 29, 2011
Date of Revision:
JAN 24, 2024
Submission Control Number: 278911
_MINT-SIMVASTATIN_
_ _
_(simvastatin) _
Page 2 of 60
_ _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Musculoskeletal
01/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
.............................................................................................................
4
1.2
Geriatrics
.............................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
5
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
Dosing Considerations
.........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...................................................... 6
4.4
Administration
.....................................................................................................
8
4.5
Missed Dose
...........................